The SAS/UK Clinical Data Management Knowledge Solution

Ian Pimblett

Pharmaceutical Business Unit

SAS/UK

Agenda

Project ReviewFunctionality StatusTechnical

Data StructureStudy DefinitionSecurityValidation & QueriesReporting

Summary

Project Review: Consultancy ProjectQ1 2000

Consultancy Project undertaken to meet the specific needs of 1 customer :

Phase IV marketing studies Did not need a validated system2 specific studies No Remote Data EntryNew SAS siteRapid solution requiredEase of use criticalSAS Version 6.12

Q2 2000

Project successfully implemented and accepted, on time and on budget:

Customer expectations exceededSite implementation and user training completed in

< 3 daysOngoing support of < 0.5 day/month (largely due to

changes in customer circumstances)

Project Review: Consultancy Project

Q2 2000

The success of this project resulted in extended awareness within the market place

The UK Pharmaceutical team carried out some market research

Project Review: Consultancy Project

Project Review: Market ResearchSystems currently available:

require substantial technical skills,require product specific training,take a long time to set-up,are not flexible enough.

Oracle & Domain:

Current Market LeadersEstablished in market placeBased on transaction databasesExtensive functionality Best suited to Clinical Phase II and III trials All export to SAS datasets

O th e r

O r a c l e & D o m a i n

Project Review: Market Research

Niche Players:

More specific usageBetter suited to smaller trials Frequently written in SASSmaller vendors do not have establishedreputation within the industryPossible risk for long term support

O th e r

O r a c l e & D o m a i n

Project Review: Market Research

Project Review: Criteria to proceed

Must meet the identified gap in the market

Should not compete directly with key players

Support for:Phase I and IV Pharmaceutical trials, Animal Health trialsDiagnostics and Devices trials

Project Review: Criteria to Proceed

Incremental Development of CDMKSRelease 1 to include core functionalityAdditional functionality to follow

Must Exploit SAS Web Technology

As a result it was decided to redesign the solution with increased functionality and using latest SAS technology

Project Review: System Validation

System Validation Audit – PA Consulting

Quality System Development

Two Audits to DatePotential ClientExternal ISO 9001

21 CFR Part 11

Functionality

The system must be able to:

enter,manage,deliver clinical trial data.

Functionality

The system must also be:

validatedflexible, portable,user friendly,quick to set-up.

Meet relevant regulatory requirements

Functionality

The system to have the options:

Stand alone PCClient/ServerClient/Server + Web

Technical: Data Structure

System Keys

Primary Keys

Secondary Keys

Variables

- Book, Page, Userid, Datetime

- Patient IDs

- Visit

- Recorded observations

Technical: Study Definition

Dataset

Copy Previous Study

Use Data Dictionary

Create New Variables

Data Entry Frame

Build Environment

Web Data Entry Frame

Technical: SecurityUsers

Passwords RolesStudy & System level

Data System password protected Access only through the System

Audit TrailAll changes auditedSwitch-on controlledCannot be deleted

Technical: Validation & QueriesAt Data Entry

RangesValid valuesInformats and Formats

Validation ManagerConsistency checks using GUI interfaceMore complicated checks programmed & stored

Query ManagerResults assigned to targets e.g Investigator, CRALinked to data for drilldown

Technical: ReportingSuite of standard metrics reports

Adverse Events reportAudit reportFull data listing

User written reports may be added Study data exported to other formats

SAS datasetsExcelCSVAccess

Summary: Business Benefits Minimal training

Users can be up and running in a few hours.Rapid study set-up

Object orientated front end, enables quick and easy database build.

Data entry screens built directly from metadataPortable and flexible

Full SAS functionality & fully integrated with all other SAS products.

GREATLY SIMPLIFIES AND STREAMLINES THE PROCESS OF CLINICAL DATA MANAGEMENT

Summary: Status

Release 1.0 of Application to be available in U.K. end of May 2001Release 1.0 to include: data entry (local and/or web) and validation and query managementSubsequent Additional functionality to include:

Lab loaderAutoencoderSAE manager

Industry Knowledge CentreCDMK Solution

Presentation – Thurs 30th May 9.00 Demo Stands – Thurs 30th May 9.40